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Trial record 86 of 189 for:    BUPRENORPHINE AND NALOXONE

Prescription Opioid Addiction Treatment Study (POATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00316277
Recruitment Status : Completed
First Posted : April 20, 2006
Results First Posted : July 27, 2012
Last Update Posted : February 6, 2013
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Roger D. Weiss, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Opiate Dependence
Substance-related Disorders
Opioid-related Disorders
Interventions Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse
Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse
Enrollment 653
Recruitment Details 653 treatment-seeking outpatients dependent on prescription opioids across 10 U.S. sites.
Pre-assignment Details  
Arm/Group Title Buprenorphine/Nx With EMM Buprenorphine/Nx With SMM
Hide Arm/Group Description All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional. All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
Period Title: Phase 1 (12 Weeks)
Started 329 324
Completed 19 24
Not Completed 310 300
Reason Not Completed
Lost to Follow-up             88             75
Investigator-initiated termination             2             0
Eligible for Phase 2             220             225
Period Title: Phase 2 (24 Weeks)
Started 180 180
Completed 161 161
Not Completed 19 19
Reason Not Completed
Lost to Follow-up prior to wk 13             19             18
Discontinued intervention (jailed)             0             1
Arm/Group Title Buprenorphine/Nx With EMM Buprenorphine/Nx With SMM Total
Hide Arm/Group Description All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional. All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine. Total of all reporting groups
Overall Number of Baseline Participants 329 324 653
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants 324 participants 653 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
329
 100.0%
324
 100.0%
653
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 329 participants 324 participants 653 participants
32.9  (10.1) 33.5  (10.3) 33.2  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants 324 participants 653 participants
Female
125
  38.0%
136
  42.0%
261
  40.0%
Male
204
  62.0%
188
  58.0%
392
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 329 participants 324 participants 653 participants
329 324 653
1.Primary Outcome
Title The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1
Hide Description In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
653 study participants randomized to Phase 1 were included in analysis.
Arm/Group Title Buprenorphine/Nx With EMM Buprenorphine/Nx With SMM
Hide Arm/Group Description:
All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
Overall Number of Participants Analyzed 329 324
Measure Type: Number
Unit of Measure: participants
19 24
2.Primary Outcome
Title The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment
Hide Description In phase 2, successful outcome was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11). This outcome measure required substantial improvement but not complete abstinence.
Time Frame 12 weeks in Phase 2 period (i.e., 24 weeks into the study)
Hide Outcome Measure Data
Hide Analysis Population Description
360 participants randomized to Phase 2 were included in the analysis.
Arm/Group Title Buprenorphine/Nx With EMM Buprenorphine/Nx With SMM
Hide Arm/Group Description:
All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
Overall Number of Participants Analyzed 180 180
Measure Type: Number
Unit of Measure: participants
93 84
3.Secondary Outcome
Title The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up
Hide Description A planned secondary outcome, successful outcome at week 24, that is, 8 weeks after completion of buprenorphine-naloxone taper, was defined the same as at week 12 of Phase 2, that is abstinent from opioids during week 24 and at least 2 of the previous 3 weeks.
Time Frame 24 weeks in Phase 2 period (i.e., 36 weeks into the study)
Hide Outcome Measure Data
Hide Analysis Population Description
360 participants randomized to Phase 2 were included in the analysis.
Arm/Group Title Buprenorphine/Nx With EMM Buprenorphine/Nx With SMM
Hide Arm/Group Description:
All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
Overall Number of Participants Analyzed 180 180
Measure Type: Number
Unit of Measure: participants
18 13
4.Secondary Outcome
Title The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition
Hide Description As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain "other than everyday kinds of pain" excluding withdrawal-related pain, for at least 3 months.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
379 identified as having chronic pain at baseline in Phase 1.
Arm/Group Title Success in Phase 1 Among Participants With Chronic Pain Success in Phase 1 Among Participants Without Chronic Pain
Hide Arm/Group Description:
Patients were designated at baseline as having current chronic pain if they reported pain "other than everyday kinds of pain" excluding withdrawal-related pain, for at least 3 months.
[Not Specified]
Overall Number of Participants Analyzed 379 274
Measure Type: Number
Unit of Measure: participants
30 13
5.Secondary Outcome
Title The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition
Hide Description As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain "other than everyday kinds of pain" excluding withdrawal-related pain, for at least 3 months.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Success in Phase 2 Among Participants With Chronic Pain Success in Phase 2 Among Participants Without Chronic Pain
Hide Arm/Group Description:
Patients were designated at baseline as having current chronic pain if they reported pain "other than everyday kinds of pain" excluding withdrawal-related pain, for at least 3 months.
[Not Specified]
Overall Number of Participants Analyzed 149 211
Measure Type: Number
Unit of Measure: participants
79 98
6.Secondary Outcome
Title The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1
Hide Description As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to Phase 1 were stratified by two variables: current chronic pain and lifetime heroin use.
Arm/Group Title Success in Phase 1 Among Participants With Heroin Use Success in Phase 1 Among Participants Without Heroin Use
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 150 503
Measure Type: Number
Unit of Measure: participants
9 34
7.Secondary Outcome
Title The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2
Hide Description As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Success in Phase 2 Among Participants With Heroin Use Success in Phase 2 Among Participants Without Heroin Use
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 100 260
Measure Type: Number
Unit of Measure: participants
37 140
Time Frame Adverse Events were captured beginning at the time of randomization and every subsequent research visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buprenorphine/Nx With EMM Buprenorphine/Nx With SMM
Hide Arm/Group Description All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional. All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
All-Cause Mortality
Buprenorphine/Nx With EMM Buprenorphine/Nx With SMM
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Buprenorphine/Nx With EMM Buprenorphine/Nx With SMM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/329 (1.82%)      5/324 (1.54%)    
Gastrointestinal disorders     
Gastric Ulcer  1  1/329 (0.30%)  1 0/324 (0.00%)  0
Pancreatitis  1  1/329 (0.30%)  1 0/324 (0.00%)  0
Infections and infestations     
Pneumonia  1  1/329 (0.30%)  1 0/324 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental Overdose  1  1/329 (0.30%)  1 0/324 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  0/329 (0.00%)  0 1/324 (0.31%)  1
Hyperglycaemia  1  1/329 (0.30%)  1 0/324 (0.00%)  0
Nervous system disorders     
Grand Mal Convulsion  1  1/329 (0.30%)  1 0/324 (0.00%)  0
Psychiatric disorders     
Suicidal Ideation  1  0/329 (0.00%)  0 2/324 (0.62%)  2
Anxiety  1  0/329 (0.00%)  0 1/324 (0.31%)  1
Renal and urinary disorders     
Urinary Retention  1  1/329 (0.30%)  1 0/324 (0.00%)  0
Reproductive system and breast disorders     
Ovarian Cyst  1  0/329 (0.00%)  0 1/324 (0.31%)  1
Ovarian Torsion  1  0/329 (0.00%)  0 1/324 (0.31%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Buprenorphine/Nx With EMM Buprenorphine/Nx With SMM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   277/329 (84.19%)      265/324 (81.79%)    
Gastrointestinal disorders     
Constipation  1  42/329 (12.77%)  42 62/324 (19.14%)  64
Nausea  1  46/329 (13.98%)  48 38/324 (11.73%)  42
Vomiting  1  27/329 (8.21%)  32 30/324 (9.26%)  32
Toothache  1  19/329 (5.78%)  19 22/324 (6.79%)  25
General disorders     
Fatigue  1  18/329 (5.47%)  18 17/324 (5.25%)  18
Infections and infestations     
Nasopharyngitis  1  21/329 (6.38%)  21 15/324 (4.63%)  17
Musculoskeletal and connective tissue disorders     
Back Pain  1  16/329 (4.86%)  16 24/324 (7.41%)  26
Nervous system disorders     
Headache  1  108/329 (32.83%)  130 83/324 (25.62%)  98
Psychiatric disorders     
Insomnia  1  39/329 (11.85%)  40 47/324 (14.51%)  48
Anxiety  1  30/329 (9.12%)  30 24/324 (7.41%)  25
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA
A treatment providing infrequent or no medical management was not included. It is not known if less intensive medical management would affect outcomes. Length of the trial may have also affected results. Pain severity was only moderate on average.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roger D. Weiss, M.D.
Organization: McLean Hospital/Harvard Medical School
Phone: 617-855-2242
EMail: rweiss@mclean.harvard.edu
Other Publications:
Layout table for additonal information
Responsible Party: Roger D. Weiss, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00316277     History of Changes
Other Study ID Numbers: NIDA-CTN-0030
First Submitted: April 18, 2006
First Posted: April 20, 2006
Results First Submitted: May 8, 2012
Results First Posted: July 27, 2012
Last Update Posted: February 6, 2013